November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.

The purpose of the NIDCRDentist Scientist Career Transition Award for Intramural Investigators
(K22) program is to provide highly-qualified dentists in NIH Intramural
postdoctoral fellowship positions with an opportunity to receive further
mentored research experience in the NIH Intramural program, and then to
provide them with independent funding to facilitate the transition of their
research programs as new investigators at extramural institutions. To achieve
these objectives, the NIDCR Dentist Scientist Career Transition Award for
Intramural
Investigators will support two phases
of research: a mentored intramural phase of up to two years, and an
independent extramural phase of up to three years. Transition from the
intramural phase of support to the extramural phase is not automatic.
Approval of the transition will be based on the success of the awardee’s
research program as determined by an NIDCR progress review, which will
include an evaluation of a research plan to be carried out at the extramural
institution.

The
overall goal of the NIH Research Career Development program is to help ensure
that a diverse pool of highly trained scientists are available in appropriate scientific
disciplines to address the Nation's biomedical,
behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The purpose of the NIDCRDentist
Scientist Career Transition Award for Intramural Investigators (K22) program is
to provide highly-qualified dentists in NIH Intramural postdoctoral fellowship
positions with an opportunity to receive further mentored research experience
in the NIH Intramural program, and then to provide them with independent
funding to facilitate the transition of their research programs as new
investigators at extramural institutions. To achieve these objectives, the
NIDCR Dentist Scientist Career Transition Award for Intramural Investigators
will support two phases of research: a mentored intramural phase of up to two
years, and an independent extramural phase of up to three years. Transition
from the intramural phase of support to the extramural phase is not automatic.
Approval of the transition will be based on the success of the awardee’s
research program as determined by an NIDCR progress review, which will include
an evaluation of a research plan to be carried out at the extramural
institution.

Following the mentored phase, the individual may request
up to 3 years of support to conduct research as an independent scientist at an
extramural sponsoring institution/organization to which the individual has been
recruited, been offered and has accepted a tenure-track (or equivalent)
full-time assistant professor position (or equivalent). This support is to
allow the individual to continue to work toward establishing his/her own independent
research program and prepare an application for NIH research grant (R01) support.

Section II. Award
Information

Funding Instrument

Grant

Application
Types Allowed

New
Resubmission

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH
appropriations, and the submission of a sufficient number of meritorious
applications.

Award Budget

(Applicable to Extramural Independent phase only)

Award budgets are composed of salary and other
program-related expenses, as described below. Up to $249,000 in direct costs
per year is allowed during the extramural independent phase. This amount includes salary, fringe benefits,
research support allowance and applicable indirect costs (8%).

Award Project Period

The total extramural phase project period may not exceed 3
years.

Other Award Budget Information

Salary

Phase 1 (Intramural): Mentored candidates in the NIH Intramural Program
will be supported by intramural funds provided by the NIH Institute/Center
intramural laboratory in which they are conducting their research. Budget
details for the mentored phase will be negotiated with the sponsoring
intramural laboratory Institute/Center and salary will be consistent with
that offered new scientists in similar positions.

Phase 2 (Extramural): The total salary requested
must be based on a full-time independent tenure-track (or equivalent) faculty
appointment. The salary must be consistent both with the established salary
structure at the institution and with salaries actually provided by the
institution from its own funds to other staff members of equivalent
qualifications, rank, and responsibilities in the department concerned.

The sponsoring institution may supplement the NIH salary contribution up to a
level that is consistent with the institution's salary scale. However,
supplementation may not be from Federal funds unless specifically authorized
by the Federal program from which such funds are derived. In no case may PHS
funds be used for salary supplementation. Institutional supplementation of
salary must not require extra duties or responsibilities that would interfere
with the purpose of the career award.

NOTE: NIDCR does not
require that full salary support be derived from the K22 award. If no salary
funds are requested in the Phase 2 application, a statement should be
included indicating the source and amount of salary support.

Other Program-Related Expenses

For the independent extramural phase, research development
support costs may include salaries for technical support, consultant costs,
equipment, supplies, travel to scientific meetings and training, statistical
services, and other research-related expenses. These costs must be justified
and consistent with the stage of development of the candidate and the
proportion of time to be spent in research or career development activities.

Salary for mentors, secretarial and administrative assistants, etc. is not
allowed.

Indirect Costs

For the extramural phase, Indirect Costs (also known as
Facilities & Administrative [F&A] Costs) are reimbursed at 8% of
modified total direct costs.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Phase 1 (mentored)

The application must be submitted on behalf of the candidate
by an NIH Division of Intramural Research laboratory or branch.

Phase 2 (independent, extramural):

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education
Institutions are always encouraged to apply for NIH support as Public or
Private Institutions of Higher Education:

The extramural institution (Phase 2 of the award) may be
private (profit or nonprofit) or public.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are
not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program
Director(s)/Principal Investigator(s))

Any candidate with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program
Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her
NIH Intramural mentor and organization to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH support. Multiple
Principal Investigators are not allowed.

Only individuals affiliated with an NIH Intramural Laboratory
may apply (specific information is available for intramural candidates on the Electronic Submission Intranet –
link available only to users internal to NIH).

Candidates for this award must have earned a clinical dental
doctoral degree (DDS, DMD or equivalent), or a combined dental and research
doctoral degree (PhD or equivalent).

By the time of award, the individual must be a citizen or a
non-citizen national of the United States or have been lawfully admitted for
permanent residence (i.e., possess a currently valid Permanent Resident Card
USCIS Form I-551, or other legal verification of such status).

Former PD(s)/PI(s) on NIH research project (R01), program
project (P01), center grants, FIRST Awards (R29), sub-projects of program
project (P01) or center grants, other career development awards (K–awards), or
the equivalent are not eligible. Former principal investigators of an NIH Small
Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Awards (R36),
or SBIR/STTR (R41, R42, R43, R44) remain eligible.

Applicants should contact the
NIDCR program staff (Section VII.) for guidance and additional information.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed. An individual may not have two or more competing
NIH career development applications pending review concurrently. Resubmission
applications may be submitted, according to the NIH Policy on Resubmission
Applications from the SF 424 (R&R) Application Guide.

Candidates may submit research
project grant (RPG) applications concurrently with the K application. However,
any concurrent RPG application may not duplicate the provisions of the career
award application. K award recipients are encouraged to obtain funding from NIH
or other Federal sources either as a PD(s)/PI(s) on a competing research grant
award or cooperative agreement, or as project leader on a competing
multi-project award as described in NOT-OD-08-065.

Individuals are eligible for a K22 award if they have been,
or currently are the PD(s)/PI(s) of an NIH R03 or R21 grant or a PHS or
non-Federal award that duplicates the provisions or research goals of an R03 or
R21 grant. Individuals are NOT eligible to apply if they have pending an
application for any other PHS career development award, an NIH
institute-specific K22, or a Pathway to Independence Award (K99/R00).
Individuals are not eligible to apply if they have been or are currently a PI
on an NIH research grant (such as R01, R29, P01) or a subproject leader on a
Program Project (P01) and Center Grant (P50), or a non-NIH equivalent to these
grants/awards.

Level of Effort

At the time of selection for the Intramural mentored phase,
the candidate must have a “full-time” appointment in an NIH Intramural
Scientific Program.

At the time of award for the independent extramural phase,
the awardee must have a “full-time” appointment at an eligible institution.
Awardees who have VA appointments may not consider part of the VA effort toward
satisfying the “full time” requirement at the Phase 2 extramural institution.
Under certain circumstances, an awardee may submit a written request to the
awarding component requesting a reduction in minimum required percent effort,
which will be considered on a case-by-case basis. Details on this policy are
provided in NOT-OD-09-036.

Mentor(s)

Before submitting the application, the candidate must
identify a mentor(s) in an NIH Intramural Laboratory who will supervise the
proposed career development and research experience of the first phase of the
K22. The mentor should be an active investigator in the area of the proposed
research and be committed both to the career development of the candidate and
to the direct supervision of the candidate’s research. The mentor must document
the availability of sufficient research support and facilities for high-quality
research. The mentor, or a member of the mentoring team, should have a
successful track record of mentoring. Candidates are encouraged to identify
more than one mentor, i.e., a mentoring team, if this is deemed advantageous
for providing expert advice in all aspects of the research career development
program. In such cases, one individual must be identified as the principal mentor
who will coordinate the candidate’s research. The candidate must work with the
mentor(s) in preparing the application.

The mentor(s) should describe the career development plan for the candidate
(coordinated with the candidate’s research strategy). The mentor and any
co-mentors are also expected to provide an assessment of the candidate’s
qualifications and potential for a research career. The research environment
and the availability and quality of needed research facilities and research
resources (e.g., equipment, laboratory space, computer time, available research
support, etc.) must also be described. The description should include items
such as classes, seminars, and opportunities for interaction with other groups
and scientists. Training in career skills, e.g. grant-writing and making
effective presentations, is strongly encouraged.

Phase 2

Sponsoring
Extramural Institution: To
obtain support for Phase 2 of the award, the Phase 1 awardee must receive and
accept a formal tenure-track (or equivalent) offer at an extramural
institution. The institution must demonstrate a commitment to the individual
by providing protected research time, as well as space, equipment and
facilities needed to conduct the proposed research.

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow the instructions in the SF 424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 (R&R)
Application Guide and the Table of
Page Limits must be followed.

Other Project Information Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Project Summary/Abstract (Component
of the Other Project Information Component)

This attachment must be uploaded via the
Other Project Information Component, and must include a description of your
current research and the research you propose to continue in the independent
phase.

PHS 398 Career Development Award Supplemental Form

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Candidate’s Background (Component of
Candidate Information)

Describe prior training and research efforts, and how they relate
to the objectives and long-term career plans of the candidate.

Provide evidence of the candidate's potential to develop into a
successful independent investigator. Usually this is evident from
publications, prior research interests and experience, and letters of
reference.

Describe the candidate’s commitment to a career in a biomedical
or behavioral research field relevant to the mission of the NIDCR.

Career Goals and Objectives
(Component of Candidate Information)

Describe a systematic plan that shows a logical progression from
prior research and training experiences to the research and training
experiences that will occur during the K22 award period and then to independent
investigator status.

Candidates for the mentored phase should select a mentor with
whom the candidate can consult in preparing and submitting the application for
the intramural mentored phase of the award. Individuals working at an NIH
laboratory may work with their current mentor, or with another intramural
investigator, provided the research experience proposed in this application
will enhance the candidate’s scientific career.

Career Development/Training
Activities During Award Period (Component of Candidate Information)

The candidate and the mentor are jointly responsible for the
preparation of the career development plan. A timeline is often helpful.

Provide a description of the career development plan,
incorporating consideration of the candidate's goals and prior experience. Include
a plan to obtain the necessary research experience to launch an independent
research career. Suggested activities include, but are not limited to, those designed to improve skills and understanding in
grant writing, clinical trials methodology, research design and management,
statistical analysis, and bioethics.

The career development plan must be tailored to the needs of the
individual candidate and the ultimate goal of achieving independence as a
researcher.

Candidates must justify the need for both the mentored phase and
the independent phase, and must provide a convincing case that the proposed
period of support (1-2 years as a mentored scientist followed by up to 3 years
as an independent scientist) will substantially enhance his/her career and/or
will allow the pursuit of a novel or promising approach to a particular
research problem.

Describe professional responsibilities/activities including other
research projects that are beyond the minimum required effort commitment to the
career award. Explain how these responsibilities/activities will help ensure
career progression to achieve independence as an investigator.

Although not required, an advisory committee may be formed to
assist with the development of the program of study and to monitor the
candidate’s progress during the career development program. If an advisory
committee is planned, describe and justify the scientific composition, and the
role and responsibilities of the committee to the candidate.

The candidate and K22 Intramural phase mentor must describe the
plan for evaluation of the candidate’s progress during the mentored phase and plans
for the transition to the independent phase.

Training in the Responsible Conduct of Research (Component of Candidate Information)

Individuals are required to comply with the instructions for
Training in the Responsible Conduct of Research as provided in Chapter 7 of the
SF424 (R&R) Application Guide.

The candidate must name a primary mentor (sponsor), who, together
with the candidate, is responsible for the planning, direction, and execution
of the program. The candidate may also identify co-mentors as appropriate to
the goals of the program.

The mentor(s) should be recognized as an accomplished
investigator in the proposed research area and have a track record of success
in training individuals in postdoctoral positions who have gone on to become
independent investigators.

The mentor(s) should have sufficient independent research support
to cover the costs of the proposed research project in excess of the allowable
costs of this award.

Each mentor and co-mentor(s) must provide a statement of his/her
areas of expertise and responsibility. Co-mentors should clearly describe how
they will coordinate mentoring of
the candidate. If any of the co-mentors is not located at the sponsoring
institution, a statement should be provided describing the mechanism(s) and
frequency of communication with the candidate, including the frequency of
personal meetings.

Signed statements must be provided by all consultants/collaborators
confirming their participation in the project and describing their specific
roles. Collaborators and consultants generally do not need to provide their
biographical sketches. However, information should be provided clearly
documenting the appropriate expertise in the proposed areas of
consulting/collaboration. Collaborators/consultants are generally not directly
involved in the development of the career of the candidate as an independent
investigator.

The application must include a statement from the mentor
providing: 1) information on his/her research qualifications and previous
experience as a research supervisor; 2) a plan that describes the nature of the
supervision and mentoring that will occur during the proposed award period,
including how the Candidate’s scientific and professional independence will be
promoted; 3) a description of the elements of the planned research career
development, including any formal course work; and 4) a plan for
transitioning the candidate to move from the mentored stage of his/her career
to the independent research investigator status during the project period of
the award.

The mentor(s) must agree to provide annual evaluations of the
candidate’s progress as required in the annual progress report.

Description of Institutional
Environment (Component of Environment and Institutional Commitment to the Candidate)

The sponsoring institution must document a strong,
well-established research and career development program related to the
candidate's area of interest, including a high-quality research environment
with key faculty members and other investigators capable of productive
collaboration with the candidate.

Describe the sponsoring institution’s scientific environment
including the resources and facilities that will be available to the candidate.

Describe how the institutional research environment is particularly
suited for the development of the candidate's research career and the pursuit
of the proposed research plan and progression to the independent phase.

Institutional Commitment to the
Candidate’s Research Career Development (Component of Environment and
Institutional Commitment to the Candidate)

The NIH Intramural laboratory or branch must provide the
candidate with the appropriate facilities and other resources to carry out the
proposed Research Plan.

The NIH Intramural laboratory or branch must provide a statement
of commitment to the candidate's development into a productive, independent
investigator and to meeting the requirements of this award. It should be clear
that the institutional commitment to the candidate is not contingent upon
receipt of this career award.

The NIH Intramural laboratory or branch must provide assurances
that appropriate time and support for any proposed mentor(s) and/or other staff
consistent with the career development plan will be provided.

Research Strategy (Component of
Research Plan)

The candidate should describe his/her research that is relevant
to the proposed independent phase research plan. Ideally, this would include a
brief description of research performed prior to the mentored phase, a
description of the research planned during the mentored phase and a detailed
description of the research planned for the independent phase. This narrative
should describe what the candidate will accomplish during the mentored phase
research that will enable him/her to launch an independent research program
(i.e., what does the candidate still need to accomplish during the mentored
phase in order to compete successfully once independence is achieved). The
application must include a description of how the mentored phase research will
lead to the independent phase research.

The application must describe a sound independent phase research
project that is consistent with the candidate’s level of research development
and objectives of his/her career development plan. The research description
should demonstrate not only the quality of the candidate’s research thus far
but also the novelty, significance, creativity and approach, as well as the
ability of the candidate to carry out the research.

Appendix

Do not use the appendix to circumvent page
limits. Follow all instructions for the Appendix as described in the SF424
(R&R) Application Guide.

Letters of Reference

Candidates must carefully follow the SF424 (R&R)
Application Guide, including the time period for when letters of reference will
be accepted. Applications lacking the appropriate required reference letters will
not be reviewed (more details in the Notice).
This is a separate process from submitting an application electronically.
Reference letters are submitted directly through the eRA Commons
Submit Referee Information link and not through Grants.gov.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants are
responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of on-time submission
are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for
more information on the electronic submission process, visit Applying
Electronically.

Important reminders:All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile Component of the SF 424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD(s)/PI(s) Commons ID in the credential field will prevent the
successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for completeness
by the Center for Scientific Review, NIH. Applications that are incomplete will
not be reviewed.

In order to expedite review, applicants are requested to
notify the Chief, Scientific Review Branch by email at lynn.king@nih.gov when the application has
been submitted. Please include the FOA number and title, PD(s)/PI(s) name, and
title of the application.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Overall Impact

Reviewers should provide their assessment of the likelihood
for the candidate to maintain a strong research program, taking into
consideration the criteria below in determining the overall impact/priority
score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact.

Candidate

Does the candidate have the potential for becoming a successful
independent investigator who will contribute significantly to a chosen
health-related research field? Will the research experiences in the mentored
phase prepare the candidate to implement successfully the independent phase
research project? Do the letters of reference from at least three
well-established scientists address the candidate’s potential for becoming an
independent investigator?

Career Development Plan/Career Goals
& Objectives/Plan to Provide Mentoring

What is the likelihood that the proposed
career development activities will contribute substantially to the continued
scientific development and productivity of the candidate? Is the career
development plan consistent with the candidate’s prior research experience and
current research career goals? Are the content, phasing, and proposed duration
of the career development plan appropriate for achieving scientific
independence?

To what extent are the plans for evaluating the candidate’s
progress adequate and appropriate for guiding him/her towards a successful
transition to the independent phase of the award? Is the timeline planned for
the transition to the independent phase of the award appropriate for the
candidate’s current stage of scientific and professional development and for the
career development activities proposed for the mentored phase of the award?

Research Plan

Is the proposed research project appropriate for the candidate’s
stage of research development and as a vehicle for development of research
skills described in the career development plan?

Are the scientific and technical merits of the research question,
design, and methodology appropriate in the context of prior training and
experience? Is the proposed research relevant to stated career objectives?

Is the proposed independent phase research scientifically sound
and a logical extension of the Intramural mentored phase research? Is there
evidence of long-term viability of the proposed independent phase research
plan?

To what extent is the proposed independent phase research project
likely to foster the career of the candidate as an independent investigator in
biomedical research?

Mentor(s), Co-Mentor(s),
Consultant(s), Collaborator(s)

Are the mentor's research qualifications in the area of the
proposed research appropriate? Is there evidence of the mentor’s, consultant’s,
collaborator’s previous experience in fostering the development of independent
investigators? Is there evidence of the mentor's previous research productivity?

Do(es) the mentor(s) adequately address the candidate’s potential
and his/her strengths and areas needing improvement? Is there adequate
description of the quality and extent of the mentor’s proposed role in
providing guidance and advice to the candidate? Is the mentor’s description of
the elements of the research career development activities, including formal
course work, adequate?

Are there adequate plans for monitoring and evaluating the career
development awardee’s progress toward independence?

Does the mentor have a comprehensive plan to support the proposed
mentored phase career development and research plans as well as the candidate’s
efforts to transition to independence? Is this plan adequate and appropriate?

Environment & Institutional
Commitment to the Candidate

Are there adequate and appropriate research facilities and
educational opportunities, including collaborating faculty? Is the environment
of high quality and relevance for scientific and professional development of
the candidate? Are there unique features of the scientific environment that
benefit the proposed research; e.g., useful collaborative arrangements or
subject populations?

Is there clear commitment of the NIH Intramural laboratory or
branch to ensure that the required effort of the candidate will be devoted
directly to the research training, career development, and research activities
described in the proposed career development and research plans?

Is sufficient evidence provided that the Intramural
program is strongly committed to fostering the candidate’s development and
transition to the independent phase?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but
does not involve one of the six categories of research that are exempt under 45
CFR Part 46, the committee will evaluate the justification for involvement of
human subjects and the proposed protections from research risk relating to
their participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement
of live vertebrate animals as part of the scientific assessment according to
the following five points: 1) proposed use of the animals, and species,
strains, ages, sex, and numbers to be used; 2) justifications for the use of
animals and for the appropriateness of the species and numbers proposed; 3) adequacy
of veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or
procedures proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will
evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Training in the Responsible Conduct
of Research

Taking into account the circumstances of the
candidate, including level of experience, the reviewers will address the
following questions. Does the plan satisfactorily address the format of
instruction, e.g. lectures, coursework, and/or real-time discussion groups? Do
plans include a sufficiently broad selection of subject matter, such as
conflict of interest, authorship, data management, human subjects and animal
use, laboratory safety? Do the plans adequately describe the role of the
sponsor/mentor or other faculty involvement in the candidate’s instruction?
Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of
instruction every four years?

Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of
the review committee.

Select Agent Research

Reviewers will assess the information
provided in this section of the application, including 1) the Select Agent(s)
to be used in the proposed research, 2) the registration status of all entities
where Select Agent(s) will be used, 3) the procedures that will be used to
monitor possession use and transfer of Select Agent(s), and 4) plans for
appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget
and the requested period of support are fully justified and reasonable in
relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by NIDCR, and in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall
impact/priority score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center.
Applications will compete for available funds with all other recommended
applications submitted in response to this FOA. Following initial peer review,
recommended applications will receive a second level of review by the National Advisory Dental and Craniofacial Research
Council. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

There will not be a formal Notice of Award (NoA) associated
with the mentored phase of the K22 award conducted in the NIH Intramural Program.
The awarding Institute will transmit to the successful candidate an approval
letter which will include the terms and conditions of the NIH Intramural K22 award,
as well as expectations for the transition to the independent phase of the
award.

Selection of an application for award is not an authorization to begin
performance. Any costs incurred before receipt of the NoA are at the
recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs.

Transition from the mentored phase to the independent phase
is not automatic. Approval of the transition will be based on the success of
the awardee’s research program as determined by annual scientific reviews and
by the evaluation of a research and career development plan to be carried out
at the institution. Additionally, the sponsoring institution must demonstrate a
commitment to the candidate by providing a minimum of nine person-months (75%
full time professional effort) protected research time, space and resources
needed to conduct the proposed research project and appropriate scientific
mentoring. A plan for career development that will lead to research
independence and the ability to successfully compete for research support is
essential. NIH will conduct a formal scientific progress review no later than
two months before the end of the mentored phase.

Candidates must provide a progress report using form PHS 2590,
which should detail progress achieved on the specific aims of the Research Plan
and on the pursuit of identified career and career development goals. Future
goals for the research project and for further career development should also
be indicated. The mentor must provide a separate narrative of the research and
career development of the candidate.

Form PHS 2590 must include the following:

A description of the proposed research.

A description of the institutional environment, including:
research facilities and the availability of appropriate educational
opportunities, including collaborating faculty, when necessary; quality and
relevance of the environment for scientific and professional development of the
candidate.

Information about the sponsoring institution’s commitment to the
candidate and to the candidate’s scientific independence, including: commitment
to ensuring that the candidate’s effort required by the K22 program will be
devoted directly to the research and career development activities described in
the proposed career development and research plans; institutional commitment to
fostering the career development of the candidate.

Position Description: the institution should provide a detailed
description of the candidate’s position, responsibilities, and duties. The
institution’s tenure-track policy should be defined or a description should be
provided of the equivalent arrangements for institutions without a formal
tenure-track.

Budget in detail, including justification for all requested
funds:

List the name, role on project and percent effort for all project
personnel (salaried and unsalaried) and provide a narrative justification for
each person;

Identify all consultants by name and organization affiliation and
describe the services to be performed;

Provide a narrative justification for any major budget items, other
than personnel, that are requested for the conduct of the project;

Describe specific resources committed by the sponsoring
institution to support the Candidate’s research.

Consistent with NIH Policy, the extramural institution must
ensure that:

all sites engaged in research involving human subjects have an
appropriate OHRP-approved Assurance and an IRB approval of the research, and

all sites are operating in
accordance with an approved Animal Welfare Assurance and provide verification
that the IACUC has reviewed and approved those sections of the application that
involve use of vertebrate animals, in accordance with the requirements of the
Policy.

If IRB and/or IACUC approval has not been obtained in time
for the transition application, a restricted award will be made until such
approvals are granted and documentation is provided to NIDCR.

A final progress report, invention statement, and the
expenditure data portion of the Federal Financial Report are required for
closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

4. Evaluation

In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program. Accordingly, recipients are hereby notified that
they may be contacted after the completion of this award for periodic updates
on various aspects of their employment history, publications, support from
research grants or contracts, honors and awards, professional activities, and
other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Special Note: Prospective applicantsshouldconsult the Program Contact to make sure that their applications comply with the requirements of NIDCR.
Prior consultation with NIDCR staff is strongly encouraged.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.